United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2012_register executive 2012-11-28 article Notices D09002ee1c7fc248f D09002ee1c7fc24e2 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved injectable drug products containing sodium nitrite labeled for the treatment of cyanide poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of cyanide poisoning, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Cyanide antidotes carry serious risks and some unapproved drug products may lack Boxed Warnings and other warnings required in the labeling of approved cyanide antidotes. These unapproved drug products compete with approved products, and thus pose a direct challenge to the drug approval system. Injectable drug products containing sodium nitrite or sodium thiosulfate that are labeled for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in order to be legally marketed. 77 FR 71006 https://www.govinfo.gov/app/details/FR-2012-11-28/2012-28773 2012-28773 fr28no12-44 4160-01-P Docket No. FDA-2012-N-1134 https://www.govinfo.gov/app/details/FR-2012-11-28/2012-28773 https://www.govinfo.gov/content/pkg/FR-2012-11-28/html/2012-28773.htm https://www.govinfo.gov/content/pkg/FR-2012-11-28/pdf/2012-28773.pdf 3 p. 71006 71008 77 FR 71006 Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for the Treatment of Cyanide Poisoning; Enforcement Action Dates; Federal Register Vol. 77, Issue NOTICE 2012-28773 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-11-28 Docket No. FDA-2012-N-1134 4160-01-P 2012-28773 Notice.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved injectable drug products containing sodium nitrite labeled for the treatment of cyanide poisoning and unapproved injectable drug products containing sodium thiosulfate labeled for the treatment of cyanide poisoning, and persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Cyanide antidotes carry serious risks and some unapproved drug products may lack Boxed Warnings and other warnings required in the labeling of approved cyanide antidotes. These unapproved drug products compete with approved products, and thus pose a direct challenge to the drug approval system. Injectable drug products containing sodium nitrite or sodium thiosulfate that are labeled for the treatment of cyanide poisoning are new drugs that require approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) in order to be legally marketed.

This notice is effective November 28, 2012. For information about enforcement dates, see SUPPLEMENTARY INFORMATION, section IV. Lori Cantin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5239, Silver Spring, MD 20993-0002, 301- 796-1212, email: lori.cantin@fda.hhs.gov. Enforcement Action Dates: Sodium Nitrite Injection and Sodium Thiosulfate Injection Drug Products Labeled for Treatment of Cyanide Poisoning , eDRLS@fda.hhs.gov lori.cantin@fda.hhs.gov http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070290.pdf Vol. 77, no. 229 Office of the Federal Register, National Archives and Records Administration 2012-11-28 continuing daily deposited born digital 207 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-11-28 P0b002ee183862111 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr28no12 https://www.govinfo.gov/app/details/FR-2012-11-28 https://www.govinfo.gov/content/pkg/FR-2012-11-28/pdf/FR-2012-11-28.pdf https://www.govinfo.gov/content/pkg/FR-2012-11-28/xml/FR-2012-11-28.xml fdlp 70885 71082 DGPO 2012-11-28 2024-06-03 FR-2012-11-28 machine generated eng FR FR-2012-11-28 77 229